Kornimate/medical-research-clean huggingface dataset:
new angiotensin ii receptor blocker azilsartan study for stronger blood pressure lowering

Conditions: Hypertension

Summary: the purpose of this study is to compare blood pressure lowering effect of azilsartan with that of valsartan in japanese patients with hypertension who have already taken normal-dose angiotensin ii receptor blockers.

hypertension plays a major role in the development of cardiovascular disease. several guidelines require strict control of blood pressure for preventing cardiovascular events; however, the control is often poor. a new angiotensin ii receptor blocker (arb), azilsartan, is the first drug which is superior to other arbs in blood pressure lowering in phase iii clinical trials in japan. we try to evaluate effect of azilsartan on blood pressure lowering in japanese patients with hypertension who have already taken normal-dose arbs, and to compare it with that of valsartan.

Eligibility criteria:
inclusion criteria: * hypertensive patients treated with normal-dose angiotensin ii receptor blockers (arbs) in japan * normal-dose arbs in japan are defined as follows: losartan potassium 50 mg, candesartan cilexetil 8 mg, valsartan 80 mg, telmisartan 40 mg, olmesartan medoxomil 20 mg, or irbesartan 100mg per day. exclusion criteria: * hypersensitivity for azilsartan and valsartan * pregnant female * history of azilsartan use within 3 months

Keywords: hypertension angiotensin ii receptor blocker azilsartan valsartan
women engaging in quitting smoking together

Conditions: Smoking Cessation

Summary: the long-term goal of this program of research is to develop and disseminate an efficacious, group-based distress tolerance treatment for weight concern (dt-w) that will significantly increase smoking cessation rates among women. the objective of this project is to conduct a preliminary randomized controlled trial (rct) (n = 60) comparing dt-w to a health education (he) comparison intervention, in which both groups also receive standard behavioral smoking cessation treatment (st) including counseling and transdermal nicotine patch (tnp), and examine potential mechanisms that may underlie the efficacy of dt-w in improving smoking outcomes at 1-, 3-, and 6-month follow-ups.


Eligibility criteria:
inclusion criteria: female * at least 18 years of age * smoke 5 or more cigarettes per day * daily smoker for at least the past year * report motivation to quit smoking in the next month of at least 5 on a 10 point scale * report concern of at least 50 on at least one of two 100 point scales assessing weight concern * able to travel to study location for study appointments exclusion criteria: * current use of other smoking cessation or weight loss therapies * current use of other tobacco products at least weekly * diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months * lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder * score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder * current suicidality or homicidality * medical condition that is a contraindication for the use of transdermal nicotine patch * lives at same address as current or past participant
evaluation of interferon-gamma responses to hcmv infection in hiv positive individuals

Conditions: HIV Infection; CMV Infection

Summary: the study is designed to evaluate interferon responses to cmv in hiv positive individuals and a component will look at interferon responses to cmv in hiv positive individuals over time after commencement of antiretroviral therapy. we will also look at the correlation between cd4 t cell numbers and hla type with the interferon response.


Eligibility criteria:
inclusion criteria: 1. hiv positive with history of documented hcv infection 2. over 18 years old 3. hiv positive 4. antiretroviral naive, starting on antiretroviral therapy

Keywords: treatment naive hiv
a study of the pharmacokinetics of two formulations of mk-1006 (mk-1006-010 am1)(completed)

Conditions: Type 2 Diabetes

Summary: this study will assess the pharmacokinetics of two formulations of mk-1006. the primary hypothesis of this study is that the mk-1006 area under the curve (0 to infinity) and maximum concentration after administration of a single 80 mg dose of the dry filled capsule (dfc) and film coated tablet (fct) formulations of mk-1006 will be similar.


Eligibility criteria:
inclusion criteria: * is a male or a female of non-child bearing potential * has type 2 diabetes (t2d) and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent(s) * has been a nonsmoker for at least 6 months exclusion criteria: * has a history of stroke, chronic seizures, or major neurological disorder * has a history of major endocrine (except t2d), gastrointestinal, cardiovascular, blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases * has a history of cancer, except certain skin or cervical cancers or cancer that was successfully treated more than 10 years prior to screening * has unstable or rapidly progressing diabetic retinopathy and/or neuropathy * has had an eye infection or other inflammation of the eye in the 2 weeks prior to screening * has glaucoma or is blind * has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3 months (lasik is permitted) * has a history of type 1 diabetes * has symptomatic coronary artery disease * consumes excessive amounts of alcohol and/or caffeine
seretide 50/500mcg versus tiotropium bromide on exacerbation rates in severe chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a comparator study to assess the relative efficacy of the combination product fluticasone propionate/salmeterol 50/500 and tiotropium bromide on the rate of exacerbations of chronic obstructive pulmonary disease (copd) over a two year study interval.

a multicentre, randomised, double-blind, double dummy, parallel group, 104 week study to compare the effect of the salmeterol/fluticasone propionate combination product (seretide) 50/500mcg with tiotropium bromide 18 mcg on the rate of exacerbations in subjects with severe chronic obstructive pulmonary disease (copd)

Eligibility criteria:
inclusion criteria: * established clinical history of moderate to severe copd. * post bronchodilator fev1 of \< 50% of predicted normal. * fev1 / fvc ratio \<70%. * reversibility to 400mcg albuterol of less or equal to 10 predicted at visit 1. * free from exacerbation in the 6 weeks prior to screening. * current or former smoker with a smoking history of = 10 pack-years and has a history of copd exacerbations. exclusion criteria: * current asthma, eczema, atopic dermatitis and/or allergic rhinitis. * has a known respiratory disorder other than copd (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis). * has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study. * has undergone lung transplantation and/or lung volume reduction. * female who is a nursing mother. * requires regular (daily) long-term oxygen therapy (ltot). * is receiving beta-blockers (except eye drops). * has a serious, uncontrolled disease likely to interfere with the study. * has received any other investigational drugs within the 4 weeks prior to visit 1. * has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. * has a known or suspected hypersensitivity to beta2-agonists, inhaled corticosteroids, anticholinergic agents or any components of the formulations (e.g. lactose or milk protein).

Keywords: fluticasone propionate/salmeterol combination tiotropium seretide copd exacerbation
liver fibrosis evaluation using ultrasound shear wave imaging

Conditions: Liver Fibrosis

Summary: the researchers are trying to assess the effectiveness of a new ultrasound technique for non-invasive evaluation of liver fibrosis.

utilizing vibrating transducer, receiver and speaker in differing sequences, while collecting ultrasound liver tissue elastography measurements during participant breath holds. participants fast for a minimum of four hours and are positioned lying on left side with knees slightly bent.

Eligibility criteria:
inclusion criteria: * healthy volunteers or patients who are scheduled for clinically indicated liver mre for fibrosis staging. * age 18 to 80. exclusion criteria: * subjects lacking capacity to consent * subjects with unreliable ultrasound or mre measurements. * pregnant women.
study of the impact of the minimum inhibitory concentration and susceptible cut-off points (clsi, eucast, and pharmacokinetics/pharmacodynamics)in prognosis of bacteremia by enterobacteriaceae

Conditions: Bacteremia by Enterobacteriaceae

Summary: provide scientific and validated data to help international authorities to set susceptible to antibiotics cut-off points in bacteremia by enterobacteriaceae


Eligibility criteria:
inclusion criteria: * \>17 years old * clinically significant bacteremia * have received treatment fulfilling all this criteria: 1. treated with an only active antibiotic with enterobacteria (association with vancomycin, linezolid, daptomycin, metronidazole or clindamycin) between: cefotaxime, ceftriaxone, ceftazidime, cefepime, amoxicillin/clavulanic, piperacillin/tazobactam, ertapenem, imipenem, meropenem, ciprofloxacin or levofloxacin 2. first antibiotic dose was administered during the first 12 hours after the time of sampling 3. the antibiotic dosage was at least the advised amount in the summary of product characteristics to patient renal function 4. the same antibiotic has been administered during at least 48 hours. exclusion criteria:

Keywords: enterobacteria bacteremia minimum inhibitory concentration susceptible prognosis
assessment of frailty in patients with advanced hepatocellular cancers

Conditions: Hepatocellular Cancer

Summary: this study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

this study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. it is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome. the assessments include: frailty score, nutritional assessment, comorbidity score and quality of life. in addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care. the assessments will be performed at baseline on entry into the study, at week 9 and week 18. there is the option for patients to also donate a blood samples for research purposes.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of hepatocellular cancer not suitable for curative treatment * seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made * who performance status 0-2 * childs pugh score a or b * written informed consent exclusion criteria: n/a -
the effect of opioid-free anesthesia in tmj surgery

Conditions: Temporomandibular Joint Disorders

Summary: this study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (omf) temporomandibular joint (tmj) surgery.

this study will enroll 60 patients undergoing tmj surgery at massachusetts general hospital. anesthetic care will be standardized according to current institutional standards of care. intraoperative clinicians will not be blinded to group assignment. patients will be randomized to one of two groups: * group 1 - opioid-free anesthesia patients: patients who are not receiving opioids but the total intravenous anesthetic during surgery. * group 2 - standard anesthesia patients: patients who undergo the standard of care and receive opioids as part of their anesthetic regimen. both groups employ strategies that are routinely used as part of standard clinical practice for tmj surgery. patients will otherwise receive the institutional standards of care for their surgical procedure and perioperative care. following intraoperative drug administration patients will be followed until discharge from the pacu to assess study endpoints while in the hospital. at the time of discharge from the pacu, members of the study team will ask the patient to compete a brief survey on their satisfaction with pain management. patients in this study will be anticipated to be discharged the same day as the surgical procedure. at the time of hospital or pacu discharge, the patient will be provided with a medication diary. this will be used to record pain medication administration in the first 48 hours after surgery, as well as any pain or complication they might experience at home.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 (inclusive) * scheduled for tmj surgery (including both unilateral and bilateral procedures) * planned arthroscopic surgical procedure * preoperative plan to discharge the same day exclusion criteria: * inability to provide written informed consent * pregnant patients * open tmj surgeries * planned overnight admission * mental status disorder or patient who are unable to communicate

Keywords: opioid
the effect of citrasate dialysate on heparin dose in hemodialysis

Conditions: Chronic Kidney Disease

Summary: an alternative to systemic heparin anticoagulation for hd is citrate dialysate (cd). cd contains a small amount of citric acid rather than acetic acid as the acidifying agent. the use of citrasate may lead to lower heparin requirements in hemodialysis. this is a randomized, double blinded, two-period crossover trial in hd patients to compare the effect of citrasate dialysis (cd) and usual acetic-acid based dialysate (ad) on heparin dose.

the investigators will perform a randomized, double-blind, two-period crossover trial in chronic hd patients to compare the effect of citrasate dialysate (cd) and usual acetic-acid based dialysate (ad) on the cumulative intradialytic heparin dose. there is a four week run in phase followed by two weeks of intervention ad or cd followed by the remaining ad or cd intervention. the primary outcome is change in intradialytic heparin dose achieved with citrasate compared with acetate dialysate. secondary outcomes are the effect of cd compared with ad on systemic anticoagulation, bleeding time after hd, metabolic parameters, dialysis adequacy, inflammation, hemodynamic stability, and intra-rater and inter-rater reliability of the dialyzer clotting score.

Eligibility criteria:
inclusion criteria: * chronic stable hd patients ≥ 18 years * on hd at least three times per week for at least 3 months exclusion criteria: * contraindication to heparin * currently using heparin-free hd * known clotting disorder * on warfarin therapy * dialyzing with a dysfunctional central venous catheter (blood flow rates consistently less than 300ml/min and/or frequent use of thrombolytic) * history of vascular access dysfunction * planned vascular access conversion or procedure during the study period * use of high calcium dialysate * active medical issue requiring hospitalization * planned kidney transplant during the study period * planned conversion of dialysis modality (peritoneal dialysis, nocturnal dialysis) during the study period * unable to provide informed consent

Keywords: hemodialysis dialysate acetate based dialysate citrasate dialysate heparin anticoagulation hemodynamic stability
phase 3/safety & efficacy of esomeprazole in infants

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (gerd). this research study consists of a screening, open-label, and double-blind treatment withdrawal phase. the screening phase ensures the patient eligibility. no study medication is dispensed during the screening phase. during the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. during the double-blind phase, the patients are administered either his/her open-label dose or placebo. double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. the patient will have an equal chance of receiving esomeprazole or placebo.


Eligibility criteria:
inclusion criteria: * patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations) * patients must have symptoms at study entry and have a clinical diagnosis of suspected gerd, symptomatic gerd, or gerd proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams exclusion criteria: * patients who have used a ppi (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (day 0) * patients with a history of acute life-threatening event

Keywords: pediatrics neonates
prevalence and clinical significance of anti-annexin a2 antibodies in covid-19 infection

Conditions: COVID-19

Summary: in january 2020, researchers isolated and sequenced in china from patients with severe atypical pneumonia a novel coronavirus called severe acute respiratory syndrome coronavirus 2 (sars-cov-2). coronavirus disease 2019 (covid-19) caused by sars-cov-2 has rapidly spread throughout the world. sars-cov-2 may trigger hyperstimulation of immune system with an autoinflammatory response but also the development of an autoimmune process. these autoimmune responses may also develop through the molecular mimicry between virus and human-self components. multiple autoantibodies have been described in covid-19 patients. annexin a2 (anxa2), an endothelial cell receptor for plasminogen and tissue plasminogen activator has been identified as a new autoantigen in antiphospholipid syndrome. anxa2 has been identified as candidate autoantigen recognized by sars patient sera. anxa2 contributes also to pulmonary microvascular integrity. these data lead to identify anti-anxa2 antibodies in covid-19 patient sera and to know if the presence of these antibodies is associated with pulmonary injury or thrombosis in covid-19 and represents a marker of severity.


Eligibility criteria:
inclusion criteria: * 18 years and older * all patients hospitalized in amiens university hospital with covid-19 infection exclusion criteria: * autoimmune diseases * chronic viral infection by hepatitis b virus, hepatitis c virus or human immunodeficiency virus (hiv) * immunosuppressive treatment * solid tumors * hematological malignancies

Keywords: covid-19 annexin a2
a study to investigate the safety and efficacy of undiluted intravenous infusion of i.v.-hepabig inj.

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of i.v.-hepabig inj. in post-liver transplant patients


Eligibility criteria:
inclusion criteria: 1. aged ≥19 and ≤65 years at the time of signing the consent form 2. hbsag(+) before liver transplantation 3. subjects who had history of liver transplantation due to hbv-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis b recurrence 4. subjects who have been received i.v.-hepabig inj more than 3 times dose of 10,000international unit/4weeks regimen, and whole duration of administration of i.v.-hepabig ing will not be exceeded 1 year while participating this study exclusion criteria: 1. subject with history of anaphylaxis to any component of the investigational product 2. pregnant or breast-feeding women 3. deficiency of immunoglobulin a 4. clinically significant renal diseases (serum creatinine \>2.0mg/dl, anuria, renal failure or on dialysis at screening) 5. hemophilia 6. co-infection with hepatitis a virus, hepatitis c virus, or human immunodeficiency virus 7. subject with history of malignancy within the last 5 years (excluding primary liver cancer) 8. subject received estrogen or hormone replacement therapy within 3 months before screening 9. hbsag or hbeag or hbv dna positive at screening 10. anti hbs titer less than below criteria at screening \ 500 iu/l for subject whose hbeag and hbv dna were positive(+) before liver transplantation 11. subject with history of drug abuse 12. participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening 13. subject who are determined disqualified to join clinical trials by investigator

Keywords: hepatitis b liver transplantation hepatitis b immunoglobulin liver diseases
the effects of whey protein supplements on markers of exercise-induced muscle damage in resistance-trained individuals

Conditions: Muscle Damage; Muscle Soreness

Summary: intense exercise can bring about various side effects to one's body. less range of motion, increased pain sensitivity, increased muscle swelling, and decreased muscle strength can occur immediately after exercise. these side effects can be referred to exercise induced muscle damage (eimd) and can sometimes last many days. this study's goal is to evaluate the effects of various protein supplements on eimd symptoms as well as on blood vessel health during the recovery period after muscle damaging exercise.

eccentric exercise can result in exercise induced muscle damage (eimd), which can cause an abundance of ultrastructural muscular disruption and pro-inflammatory and pro-oxidant activity in the body, leading to an impairment of muscular force production and range of motion, along with elevated pain sensitivity, increased swelling, and arterial stiffness. pasture-raised dairy products, obtained from strictly grass-fed cows, have been shown to possess more anti-inflammatory-, antioxidant-, and antihypertensive-like biochemicals compared with conventional products (i.e., with a different nutrient composition from a diet rich in grains versus grasses). however, human research trials on these products, such as whey protein concentrate (wpc), are neglected. this study addresses this gap, with a double-blind, randomized, placebo-controlled trial that compares the effect of conventional wpc versus wpc supplementation reported to be derived from pasture-raised cows on vascular function and indirect markers of muscle damage and inflammation in response to eccentric eimd in healthy, young, resistance-trained women and men. thirty resistance-trained individuals will complete an intense eimd bout consisting of eccentric barbell back squats and then will be assessed 24, 48, and 72 hours post-eimd for muscle soreness, range of motion, maximal isometric voluntary contraction, peripheral fatigue via magnetic stimulation, countermovement jump, barbell back squat velocity, and vascular function (i.e., arterial stiffness via carotid femoral pulse wave velocity). subjects will be grouped into a conventional wpc, pasture-raised wpc, and placebo supplementation group and consume their respective supplementation thrice daily immediately post-eimd until the study's completion.

Eligibility criteria:
inclusion criteria: * men and women 18-40 years old * ≥3 months uninterrupted training of ≥3 days/week of resistance training * self-reported to be healthy exclusion criteria: * not within defined age range * history of allergy to dairy products * history of experiencing pain while exercising in the lower extremities (i.e., hips/knees) * current use of anti-inflammatory/anti-pain medication (i.e., nonsteroidal anti-inflammatory drugs (nsaids) such as tylenol, advil, or aleve * are pregnant or could possibly be pregnant by self-report * people who answer 'yes' to any of the pre-participation screening questions on the par-q questionnaire.